Trial Design

DOI: 10.4244/EIJ-D-23-00567

A double-blind, randomised, placebo-controlled trial of the coronary sinus Reducer in refractory angina: design and rationale of the ORBITA-COSMIC trial

Michael J. Foley1,2, MBBS, BSc; Christopher A. Rajkumar1,2, MBBS, BSc; Fiyyaz Ahmed-Jushuf1, MBBS, BSc; Florentina Simader1, MD; Rachel H. Pathimagaraj1,2, BSc, MBChB; Sukhjinder Nijjer1,2, MBBS, PhD; Sayan Sen1,2, MBBS, PhD; Ricardo Petraco1,2, MBBS, PhD; Gerald Clesham3, MA, PhD, FRCP; Thomas Johnson4, MBBS, MD, FRCP; Frank E. Harrell Jr5, PhD; Peter Kellman6, PhD; Darrel Francis1,2, MD, MA, MBBChir; Matthew Shun-Shin1,2, MA, PhD, BMBCh; James Howard1,2, MA, MBBChir, PhD; Graham D. Cole1,2, MA, MBBChir, PhD; Rasha Al-Lamee1,2, MBBS, MA, PhD

Abstract

The coronary sinus Reducer (CSR) is an hourglass-shaped device which creates an artificial stenosis in the coronary sinus. Whilst placebo-controlled data show an improvement in angina, these results are unreplicated and are the subject of further confirmatory research. The mechanism of action of this unintuitive therapy is unknown. The Coronary Sinus Reducer Objective Impact on Symptoms, MRI Ischaemia, and Microvascular Resistance (ORBITA-COSMIC) trial is a randomised, placebo-controlled, double-blind trial investigating the efficacy of the CSR. Patients with (i) established epicardial coronary artery disease, (ii) angina on maximally tolerated antianginal medication, (iii) evidence of myocardial ischaemia and (iv) no further options for percutaneous coronary intervention or coronary artery bypass grafting will be enrolled. Upon enrolment, angina and quality-of-life questionnaires, treadmill exercise testing and quantitative stress perfusion cardiac magnetic resonance (CMR) imaging will be performed. Participants will record their symptoms daily on a smartphone application throughout the trial. After a 2-week symptom assessment phase, participants will be randomised in the cardiac catheterisation laboratory to CSR or a placebo procedure. After 6 months of blinded follow-up, all prerandomisation tests will be...

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Volume 20 Number 3
Feb 5, 2024
Volume 20 Number 3
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